Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113282
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-06-07
Brief Title:
Efficacy of Adding Interleukin-2 to an Optimized Antiretroviral Regimen in HIV Patients in Therapeutic Failure ANRS123
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Study of the Immunological Efficacy of Adding Subcutaneous Interleukin-2 IL-2 to an Optimized Antiretroviral Regimen in HIV-1-infected Subjects Experiencing Therapeutic Failure on an Ongoing Antiretroviral Combination With a CD4 Cell Count 200mm3 ANRS 123 Trial
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Interleukin-2 IL-2 increases the number of CD4 cells in HIV-1 infected patients with a CD4 cell count over 200mm3 but its activity in patients with treatment failure and low CD4 cell counts is unknown This study will test the efficacy and safety of IL-2 with an optimized antiretroviral regimen in patients with a CD4 count below 200mm3 and a plasma viral load above 10000 HIV RNA copiesml
Detailed Description:
IL-2 is produced naturally in the body and helps CD4 cells multiply In earlier studies in HIV-infection most of the patients with a controlled viral load and a high level of CD4 count over 200mm3 who received IL-2 experienced an increase of their CD4 cell count superior to what is observed with antiretroviral therapy alone
The efficacy of IL-2 when the viral load is high and the CD4 cell count is low is not known The purpose of this multicentric national study is to compare the effects of an optimized antiretroviral regimen with or without IL-2The choice of the antiretroviral regimen will be made from a genotype resistance test
Ninety eight HIV-1-infected patients experiencing advanced treatment failure with a CD4 count below 200mm3 and a plasma viral load above 10000 HIV RNA copiesml will be randomly assigned to one of two treatment groups with or without IL-2
The group with IL-2 will receive a dose of 45 million International units by subcutaneous injection twice a day for 5 days up to a total of 8 cycles ending at Week 42 the first two cycles 4 weeks apart the following cycles 6 weeks apart
Evaluation will be done at week 52 and further at W76 The primary endpoint is the proportion of patients reaching an absolute CD4 count over 200mm3 at Week 52 Secondary endpoints include the proportion of patients increasing their CD4 count over 50mm3 between Week 00 and Week 24and between Week 00 and Week 52 the occurrence of HIV-related events drug safety and the evolution of CD4 cells and of HIV RNA and HIV DNA loads over time
The efficacy of IL-2 when the viral load is high and the CD4 cell count is low is not known The purpose of this multicentric national study is to compare the effects of an optimized antiretroviral regimen with or without IL-2The choice of the antiretroviral regimen will be made from a genotype resistance test
Ninety eight HIV-1-infected patients experiencing advanced treatment failure with a CD4 count below 200mm3 and a plasma viral load above 10000 HIV RNA copiesml will be randomly assigned to one of two treatment groups with or without IL-2
The group with IL-2 will receive a dose of 45 million International units by subcutaneous injection twice a day for 5 days up to a total of 8 cycles ending at Week 42 the first two cycles 4 weeks apart the following cycles 6 weeks apart
Evaluation will be done at week 52 and further at W76 The primary endpoint is the proportion of patients reaching an absolute CD4 count over 200mm3 at Week 52 Secondary endpoints include the proportion of patients increasing their CD4 count over 50mm3 between Week 00 and Week 24and between Week 00 and Week 52 the occurrence of HIV-related events drug safety and the evolution of CD4 cells and of HIV RNA and HIV DNA loads over time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRS123 | None | None | None |